Share this story

For years, Myriad Genetics has had a monopoly on testing two key genes related to breast and ovarian cancer, BRCA1 and BRCA2. But the Utah company's dominance was supposed to end last month. Doctors' groups, supported by the American Civil Liberties Union and the Public Patent Foundation, took their legal challenge against all patents on genomic DNA to the Supreme Court and won a unanimous decision.

"Myriad did not invent the BRCA genes and should not control them," said ACLU attorney Sandra Park, who worked on the case. "Because of this ruling, patients will have greater access to genetic testing and scientists can engage in research on these genes without fear of being sued."

One of the plaintiffs in the Myriad lawsuit, a breast cancer survivor named Lisbeth Ceriani, said that she was grateful other women wouldn't have to go through her ordeal—waiting more than 18 months for a critical test because she couldn't afford Myriad's price of more than $4,000. "I'm so glad that the Supreme Court agrees that women deserve full access to vital information from their own bodies," she said in the ACLU statement.

But while health advocates expected Myriad's dominance of testing in this area to be over, Myriad and its lawyers see things quite differently. The Supreme Court's allowance of patents on another type of genetic material—cDNA—means that Myriad can still stop competitors from offering specific types of tests relating to the genes. It has other, differently worded patents that the competing tests are still infringing, according to Myriad lawyers.

The company is still flush with genetic patents it says remain valid. It originally owned 520 valid patent claims, and the Supreme Court decision merely "reduc[ed] the overall patent estate to 24 patents and 515 patent claims," lawyers wrote in documents filed Tuesday and Wednesday.

Myriad has earned $57 million from its monopoly on BRCA1 and BRCA2 tests, the company states in court documents. It's not giving up that revenue stream without another courtroom brawl.

PubPat director Dan Ravicher, e-mailing Ars from Beijing, described Myriad's new suits as a way to save face with Wall Street. He said the Supreme Court decision was a "total loss" for Myriad, and the synthetic cDNA they are focused on now is not needed for genetic testing. "I am confident they will lose these cases, too, so long as the defendants have the financial resources and institutional desire to fight," said Ravicher.

Competitors use synthetic DNA "primers"

The new lawsuit is sure to anger advocates who were hoping for exactly the type of price competition Myriad is now trying to foreclose in court.

Just hours after the Supreme Court decision was published, two competitors launched lower-cost tests. Ambry Genetics, based in Orange County, California, immediately offered its BRCAPlus test for $2,280; Houston-based Gene by Gene offered BRCA1 and BRCA2 testing for $995. Both are steeply discounted when compared to the price of Myriad Genetics' test, BRACAnalysis, which costs $4,040.

The alternative tests have already led insurers and HMO's to pressure Myriad to lower its price, according to a Myriad executive quoted in court documents. "This could lead to a competitive response by Ambry and even lower market prices. Additionally, other competitors potentially could enter the market at even lower prices."

Both Ambry and Gene by Gene engage in two "areas of infringing activities" that Myriad says are still covered by its patents: sequencing the BRCA1 and BRCA2 genes, and preparing synthetic DNA samples for BRCA1 and BRCA2 sequencing and analysis.

In the testing process, both companies prepare short pieces of synthetic DNA called "primers." When preparing those lab-made pieces of synthetic DNA, "scientists use natural DNA sequences as inspiration," write Myriad's lawyers. The suit claims that using those primers violates claims 16 and 17 of Myriad's Patent No. 5,747,282 and claims 19 and 20 of Patent No. 5,837,492.

The new lawsuits assert 10 different patents in all. Some of them originated at the University of Utah, the same institution that shared ownership of the Myriad genetic patents that were at issue in the Supreme Court case. Patents in this case are co-owned and shared with other research institutions, including the University of Pennsylvania and the Hospital for Sick Children based in Toronto. Those institutions receive royalty payments from Myriad's testing and are also plaintiffs in this case.

The suit emphasizes Myriad's investment of more than $500 million in tracking down the BRCA1 and BRCA2 genes. It succeeded in 1994, and "this discovery was universally hailed," Myriad's lawyers note.